Natural orifice transluminal endoscopic surgery (“NOTES”) is a technique for diagnostic and therapeutic procedures whereby the peritoneal cavity, or the abdominal cavity, is penetrated through the gastrointestinal tract via a natural orifice. This differs from traditional open surgery, where a large incision is performed in the abdominal wall. NOTES also significantly differs from traditional laparoscopic surgery, which is a minimally invasive surgical technique that involves the introduction of a laparoscope into the body cavity through multiple small incisions in the abdominal wall. Laparoscopic access to the peritoneal cavity has, in many cases, proven superior to traditional open surgery as small incisions in the abdominal wall decrease postoperative pain and the risk of ventral herniation, diminish local and systemic complications, and provide an exceptional cosmetic result in comparison with open surgery. Patients also exhibit fewer postoperative ileus and recuperate rapidly after laparoscopic procedures.
NOTES represents a paradigm shift in minimally invasive surgeries and could potentially lead to a transformation in traditional endoscopy. (Giday et al. 2007). Generally, NOTES is a surgical technique whereby “scarless” abdominal operations can be performed using an endoscope that is passed through a natural orifice (e.g., mouth, urethra, anus, etc.) and advanced through an internal incision in the applicable organ or tissue (e.g., stomach, vagina, bladder or colon), thereby avoiding any external incisions or scarring. Accordingly, NOTES further decreases the invasiveness of abdominal surgeries by eliminating the need for abdominal incisions and further reducing the risk of post operative complications such as hernias and wound infections. (Kalloo 2007). In addition, NOTES has been associated with lower anesthesia requirements, faster recovery and shorter hospital stays, less immunosuppression and better postoperative pulmonary and diaphragmatic function. However, due to the nature of the procedure, it is of vital importance to have advanced flexible endoscopic tools and skills in order to accurately perform NOTES. (Giday et al. 2007).
The first transgastric endoscopic procedure was described in 1980, which reported the endoscopic insertion of a gastric feeding tube without the use of a laparotomy. (Gauderer et al. 1980; Giday et al. 2007). Successful acute studies have been performed in animal models, including transgastric liver biopsy, tubal ligation, gastrojejunostomy, cholecystectomy, splenectomy, partial hysterectomy and lymphadenectomy. There are also reports from India of transgastric appendectomy and tubal ligation in humans. (Giday et al. 2007). Further, a peroral endoscopic approach to the peritoneal cavity passing through an incision in the gastric wall has been successfully demonstrated in a porcine model. (Kalloo et al. 2004).
It is conventionally accepted that gastric remodeling can, in some cases, have a positive impact on patients who suffer from metabolic disorders and/or who are obese or morbidly obese. For example, evidence indicates that duodenal-jejunal exclusion exerts a direct impact on glucose tolerance in diabetic patients. Accordingly, and among other things, this implies that Type 2 diabetes mellitus may be rectified through surgical operations that bypass the proximal small bowel. The Roux-en-Y gastric bypass procedure (“RYGBP”) is one such procedure that has been conventionally used for obese and morbidly obese patients in order to promote weight loss and to diminish the negative health effects commonly associated with obese and morbidly obese patients.
The use of NOTES to perform RYGBP or other related procedures may prove advantageous over conventional techniques known in the art. Particularly, there are some cases where transluminal access to the peritoneal cavity may be preferred over the transcutaneous route. For example, a transgastric approach may reduce the risk of postoperative wound complications in patients who are morbidly obese, as well as in patients who have anterior abdominal wall infection or severe scarring. (Giday et al. 2007).
At least one of the complications associated with a RYGBP is the development of an anastomotic stricture at the site of a gastrojejunostomy. Such strictures are related to substantial morbidity. While diverse techniques exist for creating the gastrojejunal anastomosis in an attempt to decrease complication rates (including hand-sewing or use of a circular or linear stapler), a thirty-one percent (31%) complication rate has been observed in patients following a RYGBP with the patients developing gastrojejunal anastomotic strictures. (Carrodeguas et al. 2006). Further, many of these strictures were observed in patients more than thirty (30) days after the procedure (7.3%). (Carrodeguas et al. 2006).
Various factors account for this high complication rate. Primarily, various unresectable primary (e.g., gastric, duodenal, pancreatic) or metastatic (e.g., colorectal or renal) malignancies can generate gastric outlet and duodenal obstruction. (Carrodeguas et al. 2006; Gauderer et al. 1980; Giday et al. 2007). Further, once such an obstruction occurs, open surgery for palliation of the obstruction is related to high morbidity and mortality. (Haugh et al. 2006; Kalloo 2007). Although the laparoscopic approach is less traumatic than open surgery, the laparoscopic creation of a gastrojejunostomy is technically difficult as it requires extensive surgical and laparoscopic skills. In addition, the use of a laparoscopic technique to perform such a procedure is related to numerous complications such as anastomotic stricture (3.1% to 8.8%) and leak (1.2% to 3.0%), (Kantsevoy et al. 2005).